Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study

Hoffmann-La Roche311 enrolled

Overview

This disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment regimen measured as progression-free survival.

Study Type

OBSERVATIONAL

Enrollment

311

Conditions

Breast Cancer

Interventions

No interventionOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Initially diagnosed with HER2-positive unresectable LABC or mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time * Able and willing to provide written informed consent and to comply with the study protocol Exclusion Criteria: \- There are no exclusion criteria for entry into this study

Locations (30)

Outcomes

Primary Outcomes

Percentage of Participants Receiving Each Unique Treatment Regimen Overall

Time frame: Baseline up to approximately 8 years

Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy

Time frame: Baseline up to approximately 8 years

Percentage of Participants Receiving Each Unique Treatment Regimen Sequence

Time frame: Baseline up to approximately 8 years

Progression-Free Survival

Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.

Time frame: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)

Secondary Outcomes

Overall Survival (OS)

Time frame: From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)

Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR)

Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.

Time frame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)

Duration of Response (DoR)

Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.

Time frame: From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)

Data from ClinicalTrials.gov

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Kent & Canterbury Hospital

Canterbury, United Kingdom

Chesterfield Royal Hospital

Chesterfield, United Kingdom

Royal Cornwall Hospital; Dept of Clinical Oncology

Cornwall, United Kingdom

Castle Hill Hospital; The Queens Centre for Oncology and Haematology

Cottingham, United Kingdom

Hairmyres Hospital; Oncology Dept

East Kilbride, United Kingdom

Queen Elizabeth Hospital

Gateshead, United Kingdom

Raigmore Hospital

Inverness, United Kingdom

Forth Valley Royal Hospital ; Oncology Department

Larbert, United Kingdom

Queen Elizabeth Hospital

London, United Kingdom

Royal Marsden Hospital; Dept of Med-Onc

London, United Kingdom

...and 20 more locations

Time to Treatment Failure

Time frame: From the date of initiation of treatment to the date of treatment stopped or switched or death from any cause (up to approximately 8 years)

Percentage of Participants With Central Nervous System (CNS) as First Site of Progression

Time frame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)

Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

Time frame: Baseline up to approximately 8 years

Percentage of Participants by Reasons for Treatment Modification

Time frame: Baseline up to approximately 8 years

Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics

Time frame: Baseline up to approximately 8 years

Number of Treatment Regimens Received

Time frame: Baseline up to approximately 8 years

Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score

Time frame: Baseline up to approximately 8 years (assessed every 3 months)

Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score

Time frame: Baseline up to approximately 8 years (assessed every 3 months)

Work Productivity and Activity Impairment (WPAI) Questionnaire Score

Time frame: Baseline up to approximately 8 years (assessed every 3 months)

Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country

Time frame: Baseline up to approximately 8 years

Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens

Time frame: Baseline up to approximately 8 years

Percentage of Participants with CNS-only Disease Progression

Time frame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)

Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens

Time frame: Baseline up to approximately 8 years